Cymbalta® (duloxetine)

All FDA black box warnings are at the end of this fact sheet. Please review before taking this medication.

What is Cymbalta® and what does it treat?

Duloxetine is an antidepressant medication that works in the brain. It is approved for the treatment of major depressive disorder (MDD), generalized anxiety disorder (GAD), diabetic peripheral neuropathic pain (DPNP), fibromyalgia, and chronic musculoskeletal pain.

Symptoms of depression include:

Depressed mood - feeling sad, empty, or tearful

Feeling worthless, guilty, hopeless, and helpless

Loss of interest or pleasure in your usual activities

Sleep and eat more or less than usual (for most people it is less)

Low energy, trouble concentrating, or thoughts of death (suicidal thinking)

Psychomotor agitation (‘nervous energy’)

Psychomotor retardation (feeling like you are moving and thinking in slow motion)

Suicidal thoughts or behaviors

Generalized Anxiety Disorder (GAD) occurs when a person experiences excessive anxiety or worry for at least six months. Other symptoms include

Restlessness

Fatigue (low energy, feeling tired all the time)

Difficulty concentrating

Irritability

Muscle tension

Sleep disturbance (difficulty falling asleep or waking up in the middle of the night)

What is the most important information I should know about Cymbalta®?

Do not stop taking duloxetine, even when you feel better. Only your healthcare provider can determine the length of treatment that is right for you.

Missing doses of duloxetine may increase your risk for relapse in your symptoms.

Stopping duloxetine abruptly may result in one or more of the following withdrawal symptoms: irritability, nausea, feeling dizzy, vomiting, nightmares, headache, and/or paresthesias (prickling, tingling sensation on the skin).

Depression is also a part of bipolar illness. People with bipolar disorder who take antidepressants may be at risk for "switching" from depression into mania. Symptoms of mania include "high" or irritable mood, very high self esteem, decreased need for sleep, pressure to keep talking, racing thoughts, being easily distracted, frequently involved in activities with a large risk for bad consequences (for example, excessive buying sprees).

Medical attention should be sought if serotonin syndrome is suspected. Please refer to serious side effects for signs/symptoms.

Are there specific concerns about Cymbalta® and pregnancy?

If you are planning on becoming pregnant, notify your healthcare provider to best manage your medications. People living with MDD who wish to become pregnant face important decisions. Untreated MDD has risks to the fetus, as well as the mother. It is important to discuss the risks and benefits of treatment with your doctor and caregivers. For women who take antidepressant medications during weeks 13 through the end of their pregnancy (second and third trimesters), there is a risk that the baby can be born before it is fully developed (before 37 weeks).

Caution is advised with breastfeeding since duloxetine does pass into breast milk.

What should I discuss with my healthcare provider before taking Cymbalta®?

Symptoms of your condition that bother you the most

If you have thoughts of suicide or harming yourself

Medications you have taken in the past for your condition, whether they were effective or caused any adverse effects

If you experience side effects from your medications, discuss them with your provider. Some side effects may pass with time, but others may require changes in the medication.

Any other psychiatric or medical problems you have, including a history of bipolar disorder, kidney or liver disease

All other medications you are currently taking (including over the counter products, herbal and nutritional supplements) and any medication allergies you have

Other nonedication treatment you are receiving, such as talk therapy or substance abuse treatment. Your provider can explain how these different treatments work with the medication.

If you are pregnant, plan to become pregnant, or are breasteeding

If you drink alcohol or use drugs

How should I take Cymbalta®?

Duloxetine is usually taken 1 or 2 times per day with or without food

Typically patients begin at a low dose of medicine and the dose is increased slowly over several weeks.

The dose usually ranges from 20 mg to 120 mg. Only your healthcare provider can determine the correct dose for you.

The capsule should be swallowed whole. It should not be chewed, crushed, or broken.

Consider using a calendar, pillbox, alarm clock, or cell phone alert to help you remember to take your medication. You may also ask a family member or friend to remind you or check in with you to be sure you are taking your medication.

What happens if I miss a dose of Cymbalta®?

If you miss a dose of duloxetine take it as soon as you remember, unless it is closer to the time of your next dose. Discuss this with your healthcare provider. Do not double your next dose or take more than what is prescribed.

What should I avoid while taking Cymbalta®?

Avoid drinking alcohol or using illegal drugs while you are taking antidepressant medications. They may decrease the benefits (e.g., worsen your condition) and increase adverse effects (e.g., sedation) of the medication. Alcohol increases the risk of liver problems with duloxetine.

What happens if I overdose with Cymbalta®?

If an overdose occurs, call your doctor or 911. You may need urgent medical care. You may also contact the poison control center at 1-800-222-1222.

A specific treatment to reverse the effects of duloxetine does not exist.

To date, there are no known problems associated with long term use of duloxetine. It is a safe and effective medication when used as directed.

What other medications may interact with Cymbalta®?

Duloxetine should not be taken with or within 2 weeks of taking monoamine oxidase inhibitors (MAOIs). These include phenelzine (Nardil®), tranylcypromine (Parnate®), isocarboxazid (Marplan®), rasagiline (Azalect®) and selegeline (Emsam®).

Although rare, there is an increased risk of serotonin syndrome when duloxetine is used with other medications that increase serotonin, such as other antidepressants, migraine medications called “triptans” (e.g., Imitrex®), some pain medications (e.g., tramadol (Ultram®), and the antibiotic linezolid (Zyvox®).

Duloxetine may increase the effects of other medications that can cause bleeding (e.g., ibuprofen (Advil®, Motrin®), warfarin (Coumadin®) and aspirin).

Sleep, energy, or appetite may show some improvement within the first 1-2 weeks. Improvement in these physical symptoms can be an important early signal that the medication is working. Depressed mood and lack of interest in activities may need up to 6-8 weeks to fully improve.

Provided by the College of Psychiatric and Neurologic Pharmacists

(January 2013)

Summary of Black Box Warnings

Suicidal Thoughts or Actions in Children and Adults

Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide.

Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications. This risk may persist until significant remission occurs.

In shorterm studies, antidepressants increased the risk of suicidality in children, adolescents, and young adults when compared to placebo. Shorterm studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24. Adults age 65 and older taking antidepressants have a decreased risk of suicidality.

Patients, their families, and caregivers should be alert to the emergence of anxiety, restlessness, irritability, aggressiveness and insomnia. If these symptoms emerge, they should be reported to the patient’s prescriber or healthcare professional.

All patients being treated with antidepressants for any indication should watch for and notify their healthcare provider for worsening symptoms, suicidality and unusual changes in behavior, especially during the first few months of treatment.

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